Cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (the BICAT-NL study): study design of a prospective multicenter randomised controlled trial.

BACKGROUND: Cataract surgery is one of the most frequently performed types of surgery. Most patients suffer from bilateral cataract and while cataract surgery of only one eye is effective in restoring functional vision, second-eye surgery leads to further improvements in health-related quality of life, and is cost-effective. At present, most patients undergo cataract surgery in both eyes on separate days as recommended in national guidelines, referred to as delayed sequential bilateral cataract surgery (DSBCS). An alternative procedure involves operating both eyes on the same day, but as separate procedures, known as immediately sequential bilateral cataract surgery (ISBCS). The aim of this study is to evaluate the effectiveness and costs of ISBCS compared to DSBCS, in order to test the hypothesis that ISBCS is non-inferior to DSBCS in terms of effectiveness and superior to ISBCS in terms of cost-effectiveness. METHODS/DESIGN: Multicenter non-inferiority randomised controlled clinical trial. Patients (18 years or older) with bilateral cataract and an indication for bilateral cataract surgery with an expected uncomplicated intraoperative and postoperative course are included in the study. Patients are randomly assigned to either ISBCS or DSBCS. The primary endpoint is the proportion of patients with a refractive outcome in the second eye within 1.0 dioptre from the target refraction, at 4 weeks after surgery. Secondary outcomes include corrected and uncorrected distance visual acuity, complications, patient reported outcomes (PROMs), cost-effectiveness, and budget impact. Follow-up visits are planned at 1 week after first-eye surgery and 4 weeks after second-eye surgery. At 3 months after first-eye surgery, the occurrence of complications is checked and patients fill in a final questionnaire. DISCUSSION: This study protocol describes the design of a multicenter non-inferiority randomised controlled trial. Current studies on ISBCS often lack information on safety regarding refractive outcomes. In addition, there is a lack of well-designed cost-effectiveness studies using established methods. The BICAT-NL study will provide more insight in refractive and cost-effectiveness outcomes for ISBCS compared to DSBCS. TRIAL REGISTRATION: This study was prospectively registered at Clinicaltrials.gov on January 17th 2018. (Identifier: NCT03400124 .

The effect of bacteriochlorophyll derivative WST-D and near infrared light on the molecular and fibrillar architecture of the corneal stroma.

A cross-linking technique involving application of Bacteriochlorophyll Derivative WST-11 mixed with dextran (WST-D) to the epithelium-debrided cornea and illumination with Near Infrared (NIR), has been identified as a promising therapy for stiffening pathologically weakened corneas. To investigate its effect on corneal collagen architecture, x-ray scattering and electron microscopy data were collected from paired WST-D/NIR treated and untreated rabbit corneas. The treated eye received 2.5 mg/mL WST-D and was illuminated by a NIR diode laser (755 nm, 10 mW/cm2). An increase in corneal thickness (caused by corneal oedema) occurred at 1-day post-treatment but resolved in the majority of cases within 4 days. The epithelium was fully healed after 6-8 days. X-ray scattering revealed no difference in average collagen interfibrillar spacing, fibril diameter, D-periodicity or intermolecular spacing between treated and untreated specimens. Similarly, electron microscopy images of the anterior and posterior stroma in healed WST-D/NIR corneas and untreated controls revealed no obvious differences in collagen organisation or fibril diameter. As the size and organisation of stromal collagen is closely associated with the optical properties of the cornea, the absence of any large-scale changes following treatment confirms the potential of WST-D/NIR therapy as a means of safely stiffening the cornea.

Evaluation of the Lenstar LS 900 non-contact biometer.

BACKGROUND/AIMS: Evaluation of the reproducibility of the Lenstar LS 900 non-contact biometer, and a comparison with the Visante anterior-segment optical coherence tomography (AS-OCT) and the IOLMaster. METHODS: Central corneal thickness (CCT), anterior chamber depth (ACD), lens thickness (LT), keratometry (K) values, corneal diameter (CD) and axial length (AL) were obtained in 38 healthy volunteers (76 eyes) to determine the reproducibility of the Lenstar. CCT, ACD, CD, K values and AL measurements measured with the Lenstar were compared with the AS-OCT and IOLMaster. Intraocular lens (IOL) power calculations were done to study the significance of the difference between AL measurements. RESULTS: The reproducibility of the Lenstar was better than 0.9% for CCT, ACD, LT, K values and AL measurements. Although all correlations were highly significant (p<0.001), all comparisons showed a significant difference, except for the comparison of CD measurements using the Lenstar and IOLMaster (p = 0.175). The differences in IOL power calculations for an AL of 20, 25 and 30 mm with a mean difference between Lenstar and IOLMaster AL measurements of 0.03 mm, were 0.13 D, 0.10 D and 0.08 D, respectively. CONCLUSION: The reproducibility of the Lenstar was excellent. Small but significant differences exist between the Lenstar, Visante OCT and the IOLMaster. Therefore, measurements of the Lenstar, AS-OCT and IOLMaster are not interchangeable. Despite the significant difference between AL measurements, there is no clinically significant difference in the IOL power calculation results.

Lifetime costs and effectiveness of ReSTOR compared with a monofocal IOL and Array-SA40 in the Netherlands.

PURPOSE: To estimate the lifetime cost consequences for society and the National Health Service (NHS) of bilateral monofocal (SI40NB) or multifocal (ReSTOR or Array-SA40) intraocular lense (IOL) implantation after cataract surgery. SETTING: Public hospital in the Netherlands. METHODS: A Markov model simulated three cohorts of patients followed 69 until 100 years of age, or death. Spectacle independence rates for each IOL were adjusted to the results of a randomized clinical trial that compared monofocal and multifocal Array-SA40 IOL implants, together with a prospective cohort of patients implanted with ReSTOR. Adjustment was performed using the propensity score method in a multivariate analysis. Resource consumption was estimated from a dedicated Dutch survey. Dutch unit costs were applied to spectacles, cataract surgery, IOLs, visits to ophthalmologists, optometrists, transport, and spectacle cleaning materials. Cost discounted at 4% and undiscounted economic results were calculated. RESULTS: Spectacle independence rates were 86.0% for ReSTOR, 8.7% for monofocal IOLs, and 8.5% for Array-SA40. Patients lived without needing spectacles for 12.9 years after ReSTOR, for 1.4 years after monofocal IOLs, and 1.3 years after Array-SA40. ReSTOR patients bought 6.4 fewer pairs of spectacles than monofocal patients. Lifetime discounted cost consequences for the society were ReSTOR euro3969, monofocal IOLs euro4123, and Array-SA40 euro5326. Corresponding costs for the NHS were euro2415, euro2555, and euro2556, respectively. CONCLUSIONS: ReSTOR IOLs provided higher levels of spectacle independence than monofocal SI40NB or multifocal Array-SA40 IOLs resulting in savings, compared to a monofocal, over the period modelled of euro315 for society and euro140 for the NHS.

Determinants of surgery related anxiety in cataract patients.

BACKGROUND/AIMS: Not much is known about the relative importance of different determinants of anxiety in cataract patients. This study analysed the predictive value of factors related to surgery induced anxiety. METHODS: In 128 cataract patients, recruited from two hospitals (Medical Centre Maastricht Annadal (MCMA) and Rotterdam Eye Hospital (REH)), state anxiety was assessed at four different time points using the State-Trait Anxiety Inventory (STAI). The following predictive factors of anxiety were measured: trait anxiety, outcome expectancies, doctor-patient relationship, coping strategy, social support, information supply, sociodemographic variables, and previous cataract surgery. Repeated measures ANOVA, t tests, multiple regression analysis, and correlations were used to analyse data. RESULTS: In general patients reported little anxiety. The level of anxiety (scale 1-4) was the highest before surgery, decreased immediately after surgery, and increased again after the postoperative visit. Patients with higher trait anxiety levels (r = 0.41; p<0.01), and women (r = 0.30; p<0.01) reported more anxiety. The REH patients showed lower anxiety scores than the MCMA patients. CONCLUSION: Women and patients with higher trait anxiety were more likely to experience higher levels of state anxiety. Positive outcome expectancies and social support may decrease anxiety.

Cost effectiveness of foldable multifocal intraocular lenses compared to foldable monofocal intraocular lenses for cataract surgery.

AIM: To analyse the cost effectiveness of foldable monofocal intraocular lenses (IOLs) compared to foldable multifocal IOLs in cataract surgery alongside a prospective, multicentre randomised clinical trial (RCT). METHODS: Patients underwent cataract surgery with bilateral monofocal (n = 97) or multifocal (n = 93) IOL implantation. Cost data and patient preferences, using the visual analogue scale (VAS), the time trade-off (TTO), and the standard gamble (SG) technique were obtained preoperatively and postoperatively by structured interviews. The incremental costs (multifocal minus monofocal), mean costs per patient, and differences in preferences were computed. RESULTS: Mean costs for glasses per patient in the monofocal group were 41.67 and in the multifocal group 149.58. The difference in costs between the multifocal and monofocal group was -92.09 and was statistically significant (p = 0.008). No significant differences were found in total costs or in effectiveness between the monofocal and multifocal IOL group. CONCLUSION: The cost effectiveness of multifocal IOLs is reduced to a cost minimisation analysis, because of the inability to demonstrate significant differences in effects. The use of multifocal IOLs in cataract surgery resulted in a significant reduction in costs for patient's postoperative spectacles.

[Refractive surgery: most commonly used techniques, results and complications]. / Refractiechirurgie: meest gebruikte technieken, resultaten en complicaties.

Refractive surgery is gaining enormous popularity. It is estimated that in 2001, refractive surgery was performed on 1 in 8000 persons in the Netherlands. Photorefractive keratectomy and laser in-situ keratomileusis are effective and predictable for the correction of myopia up to 10.0 D and hypermetropia up to +4.5 D. There is rarely any significant loss of best-corrected visual acuity postoperatively. For the correction of higher levels of myopia and hypermetropia, phakic intraocular lenses can be implanted in the anterior or posterior eye chamber, in other words in front of the natural lens. The magnification effect of these lenses often results in improved vision at higher levels of myopia. Good preoperative selection of refractive surgery candidates is essential and patients should be properly informed about the results, potential complications and adverse effects of refractive surgery techniques.

Quality of care from the perspective of the cataract patient: the reliability and validity of the QUOTE-cataract.

BACKGROUND/AIMS: To assess reliability and validity of the QUOTE-cataract, a questionnaire that measures the quality of care from the perspective of cataract patients. METHODS: The QUOTE-cataract was tested in a multicentre study among 540 cataract patients in three different hospitals. Reliability was represented by internal consistency (Cronbach's alpha), and repeatability (intraclass correlation coefficient (ICC)). Validity was evaluated qualitatively and by factor analyses. RESULTS: A strong internal consistency coefficient (0.89), and high repeatability (ICC = 0.76) demonstrated good reliability. Content validity was assured by involvement of patients in the development of the questionnaire. Factor analysis confirmed an underlying taxonomy of generic and disease specific items. CONCLUSION: The QUOTE-cataract has good reliability and provides a valid assessment of quality of care in cataract surgery.

A practical approach to and long-term results of fitting silicone contact lenses in aphakic children after congenital cataract.

PURPOSE: This prospective study investigated characteristics of fit and performance of silicone contact lenses under conditions of permanent wear in cases of aphakia after congenital cataract. METHODS: Seventeen aphakic children (8 eyes unilateral, 18 eyes bilateral) were fitted with silicone contact lenses on an empirical basis without the use of keratometry. The lenses were worn on a permanent basis, with a routine replacement every 3 months. The follow up was 6 years, with evaluation lens parameters, fitting characteristics, lens condition, replacement rate, wearing time, complications, and visual acuity. RESULTS: The back optical zone radius (BOZR) remained stable at 7.50 mm, up to the age of 1.5 years old. At the age of 4 years, almost all eyes needed a BOZR of 7.90 mm. Mean +/- SD contact lens power was +25.47 diopter (D) +/- 4.0 (range +32.00 D - +20.00 D) at 3 months of age, and +17.94 D +/- 3.8 (range +29.00 D - +15.00 D) at 3 years of age. This represents an average decrease of 0.23 D per month. The power decrease in unilateral cases was significantly lower (P < 0.01) than in bilateral aphakia. Snellen visual acuity at 4 years of age was 0.1 to 0.3 (20/200-20/60) in 15 eyes, 0.3 to 0.5 (20/60-20/40) in 10 eyes and greater than 0.5 (>20/40) in 1 eye. Lens usage over a total period of 90 wearing years was 5.6 lenses/eye/year, including the regular exchange every 3 months. No serious complications occurred. A positive correlation (r = 0.89) was found between age and deposit buildup. With the need for permanent wear reduced, therefore, 73% of the eyes were refitted with high-water content soft lenses or high gas-permeable (HGP) lenses, when the patients ranged in age from 4 to 6 years old. CONCLUSIONS: The procedure for fitting silicone lenses in aphakic children is feasible in an easy and logical way without keratometry. Permanent wear with a low complication rate is possible up to the age of 3. with a lens usage (including a 3-month regular exchange) of 5.6 lenses/eye/year. From the age of 3, deposit formation is the determining factor for refitting with high-water content soft or HGP lenses.

Rigid gas-permeable contact lens fitting in LASIK patients for the correction of multifocal corneas.

BACKGROUND: Laser in situ keratomileusis (LASIK) has recently become the most commonly performed refractive surgery procedure. Results are promising in correcting low to moderate myopia. Most complications occur during the surgeon's learning curve. One of the complications is a decentration of the ablated area that causes monocular diplopia and a nocturnal halo phenomenon due to a multifocality of the corneal surface overlying the entrance pupil. The corneal shape is significantly altered after LASIK. We evaluate the efficacy of rigid gas-permeable contact lens designs and fitting techniques used in eight eyes with multifocal LASIK ablations to correct haloes and impaired night vision complaints. METHODS: We used large-diameter tetra-curved rigid gas-permeable (RGP) contact lenses for visual recovery in eight eyes of seven LASIK patients. We used the power on the transition zone of the corneal topographic map, 0.2 mm outside the ablated refractive area, for selection of the back optic zone radius of the RGP contact lenses. Procedures for lens fitting are described. Visual acuity (high-contrast logarithm of the minimum angle of resolution, LogMAR) was measured before- and 6 months after contact lens fitting. RESULTS: Large-diameter tetra-curve RGP lenses with a mean diameter of 11.85 (SD 0.16) mm were successfully used in LASIK patients with multifocal corneas. Mean best spectacle-corrected visual acuity was +0.3 LogMAR (SD 0.19; in Snellen equivalent, 20/40) and improved significantly with the contact lenses to +0.08 LogMAR (SD 0.11; in Snellen equivalent, 20/25, P=<0.01). During the follow-up period of 16.7 months, the average daily wearing time of the lenses was 12.5 h. Contact lenses with a standard geometry were not useful due to excessive movement and inadequate centration. CONCLUSIONS: Contact lenses with large diameters, in combination with selection of the back optic zone radius 0.2 mm peripheral of the refractive ablation zone, facilitate contact lens fitting to restore best-corrected visual acuity in LASIK patients with multifocal corneas.

A new technique for rigid gas permeable contact lens fitting following penetrating keratoplasty.

PURPOSE: To evaluate a new, rigid gas permeable contact lens fitting technique following penetrating keratoplasty. METHODS: For the correction of postoperative anisometropia or astigmatism, a rigid gas permeable, tetra-curve contact lens with an overall diameter of 12.0 mm and a back optic zone diameter of 8.5 mm was fitted in 36 eyes of 33 patients, 7 months after penetrating keratoplasty. The contact lens back optic zone radius was selected using the videokeratography values over the elevated edges of the transplant wound (with the sutures in place). Graft clarity, visual outcome, and corneal topography were evaluated up to 3 years after surgery at intervals of 6 months. RESULTS: Throughout the follow-up period (range 6-36, mean 19.3+/-sd 11.8 months), all grafts remained clear. Mean contact lens daily wearing time averaged 13.6 (+/- sd 4.7) hours. Mean best-corrected visual acuity improved from +0.36 (+/- sd 0.18) LogMAR with spectacles to +0.11 (+/- sd 0.11) LogMAR with contact lenses (p < 0.0001). One patient was excluded from the study due to a lack of motivation and one had an adverse reaction to the stitches. CONCLUSIONS: To improve the visual performance following penetrating keratoplasty, the described fitting technique, guided by videokeratography, eased selection of the back optic zone radius of the initial trial lens. The large diameter contact lenses with a tetra-curve design were well tolerated in all patients for more than 13 hours daily.

Phacotrabeculectomy.

The outcome of combined same-site phacoemulsification, posterior chamber lens implantation and trabeculectomy was retrospectively studied in patients with cataract and moderately controlled glaucoma, with a follow-up of at least 6 months. Primary phacotrabeculectomy without antimetabolites was performed in 74 patients. Mean IOP decreased from 22.8 to 14.3 mm Hg (35.3%). A maximum IOP of 19 mm Hg without glaucoma medication was reached in 66.2%. Mean logMAR visual acuity increased from 0.58 to 0.30. Primary phacotrabeculectomy has been shown to be a safe and effective procedure with good IOP control and rapid visual rehabilitation.

Evaluation of a new system of lens parameter selection and comparison of traditional vs one-step lens care systems for aspheric high-Dk RGP contact lenses.

PURPOSE: We investigated the value of newly developed systems for parameter selection on the performance of high Dk rigid gas permeable (RGP) contact lenses with a spheric-aspheric design made of Boston Equa material in normal daily wear conditions. A comparison was also made between the safety and efficacy of a traditional care system vs a one-step chemical care system during the follow-up period of 1 year. METHODS: A total of 66 patients were randomly assigned to traditional and newly developed systems for computing the back optical zone radius (BOZR) and the total diameter (TD) of the lenses. Evaluation parameters incorporated assessment of fit, visual acuity, wearing time, comfort, and lens condition. RESULTS: The traditional method of computing the BOZR, using a method based on flat-K, predicted the BOZR successfully in 83% of the cases. Corneal topometry reached a lower, but not significantly different (P > 0.01) value of 75% correct prediction of BOZR. Analysis of the differences in eccentricity (E) values between quadrants per eye was a significant (P < 0.001) factor in fault predictions in the topometric system. A newly developed guide forTD selection performed, with 90% correct predictions, significantly (P < 0.01) better than a traditional method (72%) based on corneal diameter on supraversion. No significant differences (P > 0.05) were found in the capabilities of care systems (a traditional care system using a surfactant cleaner vs a one-step solution) to keep the lenses in proper condition and without deformation, over the 1 year follow-up period. The final success rate was 85%. CONCLUSIONS: Although high Dk RGP contact lenses can be fit and used with a 85% success rate using advanced systems for determining the BOZR and TD, it remains necessary to evaluate the fit before dispensing high Dk RGP lenses in 15% of the cases. The one-step solution used in this study was a good starting point for lens care. If needed, surfactant cleaning in the traditional care system can be done without the risk of lens deformation.

Determinants of patient satisfaction after cataract surgery in 3 settings.

PURPOSE: To analyze the determinants of satisfaction and postoperative visual function after cataract surgery in 3 settings in The Netherlands. SETTING: University Hospital Maastricht (outpatient care), Atrium Medical Center Heerlen (inpatient care), and Medical Center Maastricht Annadal (outpatient care), Maastricht, The Netherlands. METHODS: This cross-sectional study consisted of 150 patients of 50 years and older who had first-eye phacoemulsification with intraocular lens implantation. Data were collected by a written questionnaire. The following parameters were measured: medical outcome, postoperative function, patient satisfaction with medical outcome and hospital care, and overall patient satisfaction. RESULTS: In general, patients were very satisfied (mean score 8.43 on a 10-point scale ranging from 1 = very bad to 10 = excellent). The 3 centers did not differ regarding the patient satisfaction (P =.092). However, postoperative visual function (P =.012), counseling (P =.010), and waiting time (P <.001) were different among the settings. Patient satisfaction with hospital care had a stronger correlation with overall satisfaction than patient satisfaction with the medical outcome (r = 0.669 versus r = 0.543, respectively). CONCLUSIONS: A causal model of patient satisfaction was tested, indicating that satisfaction was related to the patient's preoperative expectations and the quality of care given during the hospital stay and follow-up at the outpatient clinic. This emphasizes the relevance of patient education (to set realistic expectations) and counseling (need for care) by hospital staff in a cataract surgery setting.

Biodegradable three-dimensional networks of poly(dimethylamino ethyl methacrylate). Synthesis, characterization and in vitro studies of structural degradation and cytotoxicity.

In ophthalmology, there is a need for novel degradable biomaterials for e.g. controlled drug release in the vitreous body. These degradable materials should feature both excellent biocompatibility, and well-defined kinetics of degradation. In most cases, poly(D,L-lactic acid), or poly(lactic-co-glycolic acid) are used. These materials, however, suffer from some serious drawbacks, since the degradation kinetics are difficult to control, especially since the so-called 'burst-degradation' occurs. Here, we describe a set of novel polymeric networks which largely consist of poly(dimethylamino ethyl methacrylate) (poly(DMAEMA)); these materials are crosslinked via a dimethacrylate molecule that contains two carbonate groups. This system is susceptible to hydrolytic scission. The degradation products do not exert a catalytic effect on the ongoing degradation reaction (i.e. there is no burst effect). We describe the synthesis of three of these materials, which differ merely with regard to the crosslinker content. These materials were characterized through DMTA, 1H NMR and FT-IR spectroscopy, and scanning electron microscopy. The reaction DMAEMA + 2-hydroxyethyl methacrylate (HEMA) was studied in detail, using 1H NMR spectroscopy, and these experiments revealed that the reaction of DMAEMA and HEMA produces a random (Bernouillian-type) copolymer. From this, we contend that the new materials have more or less uniform distribution of the crosslinks throughout their volume. Structural degradation of the three materials was studied in vitro, at pH 7.4, 9.1 and 12.0. It is found that the materials exhibit smooth hydrolysis, which can be controlled via the crosslink density and the pH, as was expected a priori. It should be noted that degradation of these materials produces non-hydrolysable, but water-soluble, oligo(DMAEMA) and poly(DMAEMA) molecules. We subsequently performed in vitro studies on the biocompatibility of these materials. The MTT cytotoxicity assay revealed that the materials were cytotoxic to chondrosarcoma cells. This is most probably due to local increase of the pH due to the basic character of the pending dimethylamino groups. Cytotoxicity remained virtually unchanged after extended washing with water. This indicates that the cytotoxicity is an intrinsic property of the material and was not caused by remnants of free monomer. Cytotoxicity was also seen in cell cultures (human fibroblasts isolated from donor corneas) which were grown in contact with the materials. It is concluded that the new materials have attractive degradation characteristics, but their cytotoxicity makes them unsuitable for applications in ophthalmology.

Tailoring of new polymeric biomaterials for the repair of medium-sized corneal perforations.

The aim of this study was to investigate whether polymeric biomaterials can be designed such that they become suitable for surgical closure of medium-sized perforations in the cornea, the transparent tissue in the front of the eye. Such a biomaterial must meet stringent requirements in terms of hydrophilicity, strength, transparency, flexibility, and biocompatibility. Four different copolymers of n-butyl methacrylate (BMA) and hexa(ethylene glycol) methacrylate (HEGMA) were prepared and characterized. Poly(BMA) was made as a reference material. Physicochemical properties were measured (contact angles, glass-transition temperatures, thermal degradation, water uptake and swelling), and cytotoxicity in vitro was assessed with a MTT test. Moreover, the interaction between the materials and cultured human corneal epithelial cells was studied. The copolymers may be useful for temporary closure of corneal perforations.

Autologous limbal transplantation in unilateral chemical burns.

PURPOSE: To describe the results of autologous limbal transplantation in the treatment of unilateral chemical burns. PATIENTS AND METHODS: Two patients, a 40-year-old male (case 1) and a 35-year-old male (case 2), experienced grade III chemical trauma and were treated with autologous limbal grafting (case 1) after a postaccident period of 3 and 9 months, respectively. Change in visual acuity, epithelial healing time and postsurgical topography healing patterns were documented. RESULTS: Snellen visual acuity improved from 0.1 to 1.0 in both cases. Epithelial healing time for cases 1 and 2 were 4 and 2 weeks, respectively. Corneal topography of case 1 showed an induced inferior steepness type of asymmetrical astigmatism in the graft area. Serial topography showed no induced astigmatism in the donor eyes. CONCLUSION: Autologous limbal grafting is an adequate treatment for selected cases of unilateral chemical burns and facilitates rapid improvement in visual function. Early limbal grafting in case 1 resulted in rapid re-epithelialization and prevention of complications.

Mitomycin C primary trabeculectomy in primary glaucoma of white patients.

PURPOSE: To evaluate the clinical outcome of eyes which underwent primary trabeculectomy with adjunctive mitomycin C (MMC) for primary glaucoma. PATIENTS AND METHODS: A prospective analysis of 25 eyes in 23 patients who underwent primary trabeculectomy with MMC for primary glaucoma was performed. Clinical outcome measures including postoperative intraocular pressure, change in logarithm of the minimum angle of resolution (LogMAR) visual acuity, and incidence of complications were measured up to 1 year postoperatively. RESULTS: Mean intraocular pressure decreased from 26.0 +/- 4.4 mmHg preoperatively to 12.5 +/- 3.9 mmHg (p < 0.0001) 1 year postoperatively. The mean LogMAR visual acuity changed from 0.23 +/- 0.19 preoperatively to 0.23 +/- 0.20 1 year postoperatively (p = 1.0). One eye developed a temporary hypotonous maculopathy and 4 eyes progressed in cataract formation. CONCLUSION: Primary trabeculectomy with MMC in eyes with primary glaucoma showed excellent pressure reduction. There were no cases of persistent hypotonous maculopathy or bleb endophthalmitis.