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PubMed2003

Glaucoma clinical trials and what they mean for our patients.

PURPOSE: To provide a perspective on the several randomized clinical trials in glaucoma, to suggest how their results can be used in clinical practice, and to look to the future of glaucoma therapy. DESIGN: A search and review of the glaucoma clinical trials literature, the glaucoma observational studies literature, and the evidence-based medicine literature. METHODS: Analysis of the significance of glaucoma clinical trials data on patient management along with use of patient data to demonstrate how treatment decisions can be used in the practice setting. RESULTS: Glaucoma clinical trials and observational studies strongly support the need to reduce intraocular pressures (IOP) substantially and to maintain those pressures in patients with advanced glaucoma. Whether this aggressive therapy occurs by medications or by filtering surgery does not seem as important as that the treatment is effective and sustained. However, there is not the same strength of evidence for aggressive treatment or even any treatment for most patients with ocular hypertension and for some cases of early glaucoma. Because about half of the patients with open-angle glaucoma will have IOPs less than 21 mm Hg, these patients need to be detected through careful optic disk and visual field assessment. Once patients are detected and treated appropriately, blindness from open-angle glaucoma is unlikely. CONCLUSIONS: The goal of managing ocular hypertension and glaucoma is not to preserve every ganglion cell, but rather to preserve a patient's visual ability to conduct activities of daily living. Risk factors for damage need to be assessed for individual patients and each patient managed as an individual and not as the "average" patient depicted in the results of clinical trials. In the future, neuroprotective therapy other than IOP reduction will provide another means to control glaucoma damage.

Clinical Trials as Topic↗

PubMed1990

Primate trabeculectomies with 5-fluorouracil collagen implants.

Bilateral trabeculectomies were performed on four normal cynomolgus monkeys. Highly purified bovine skin collagen implants with either 1 mg of 5-fluorouracil or physiologic saline (one each per monkey by randomized, masked assignment) were sutured under the scleral flaps. The randomization code was not broken until all clinical and histopathologic observations had been completed. Six weeks postoperatively, the 5-fluorouracil-treated eyes had more deeply open internal trabeculectomy ostia than the control eyes; however, the intraocular pressures were indistinguishable, the filtering blebs were only minimally different, and half of each group had trace or mild anterior subcapsular lenticular changes. Histologically, a multinucleated foreign body giant cell reaction was evident in all of the collagen implants, but the 5-fluorouracil-treated eyes had less vigorous or delayed reactions compared to the control eyes. The collagen implant appears to be a poor drug delivery system in this model of glaucoma filtering surgery, because it incites a granulomatous inflammatory reaction.

Animals↗

PubMed1993

Trabeculectomy, phacoemulsification, and posterior chamber lens implantation with and without 5-fluorouracil.

Subconjunctival 5-fluorouracil has been an effective adjunct in glaucoma filtering surgery. We investigated the effectiveness of 5-fluorouracil in primary trabeculectomy combined with phacoemulsification and posterior chamber intraocular lens implantation (glaucoma triple procedure). Seventy-four patients were enrolled and randomly assigned into two groups to receive either no 5-fluorouracil (control patients) or low-dose 5-fluorouracil (mean total dose, 24.8 mg; mean number of injections, 5.0 +/- 1.3). The mean preoperative intraocular pressure was 20.1 +/- 5.4 mm Hg for the 5-fluorouracil group and 21.0 +/- 5.2 mm Hg for the control group (P = .48, Student's unpaired t-test). The mean number of medications was 2.2 +/- 1.0 and 2.0 +/- 1.0 (P = .49, Mann Whitney U test), respectively. At all postoperative visits, there were no statistically significant differences in mean intraocular pressures between the two groups. Mean follow-up was 13.2 months for 5-fluorouracil-treated patients and 15.0 months for control patients. At the last postoperative visit, mean intraocular pressures were 15.4 +/- 3.7 mm Hg and 15.0 +/- 5.0 mm Hg, respectively (P = .45, Student's unpaired t-test). Both groups showed comparable visual outcome (20/40 or better in 31 of 38 5-fluorouracil-treated patients [82%] vs 32 of 36 control patients [89%]) and a decrease in number of medications needed, 0.7 +/- 1.0 and 0.7 +/- 0.9, respectively (P = .96, Mann Whitney U test). Thus, 5-fluorouracil administered as in our study did not seem to have any effect in primary trabeculectomy combined with phacoemulsification and posterior chamber intraocular lens implantation.

Aged↗

PubMed1995

Adjunctive mitomycin C in primary trabeculectomy in phakic eyes.

PURPOSE: The addition of antiproliferative agents, most recently mitomycin C, has improved the outcome of glaucoma filtering surgery in eyes with a high risk of surgical failure. We conducted the present study to determine whether adjunctive mitomycin C would increase the success rate of primary trabeculectomies in phakic eyes. METHODS: Thirty-three eyes of 33 consecutive patients with phakic primary open-angle glaucoma, who were predominantly black (24 black and nine white), who underwent primary trabeculectomy with adjunctive subconjunctival mitomycin C (0.5 mg/ml for three minutes) were compared with a demographically similar historical control group of 30 eyes of 30 consecutive patients (20 black and ten white) with phakic primary open-angle glaucoma, who had undergone primary trabeculectomy without an adjunctive antifibrotic agent. RESULTS: Although the mean preoperative intraocular pressures were similar in both groups (29.0 +/- 6.4 mm Hg in the mitomycin C group and 29.5 +/- 10.0 mm Hg in the control group, P = .61), the mean postoperative intraocular pressure at each follow-up period was significantly lower in the mitomycin C group than in the control group (10.3 +/- 7.1 vs 14.5 +/- 5.1 mm Hg at six months, P = .02; 10.5 +/- 4.9 vs 14.5 +/- 4.4 mm Hg at 12 months, P = .01; and 10.0 +/- 3.1 vs 17.2 +/- 3.0 mm Hg at 18 months, P = .004, respectively). The mean number of postoperative medications was also significantly lower in the mitomycin C group (0.2 +/- 0.4 vs 1.1 +/- 1.4 medications at six months, P = .007; 0.3 +/- 0.4 vs 0.9 +/- 1.1 medications at 12 months, P = .04; and 0.3 +/- 0.5 vs 1.7 +/- 1.2 medications at 18 months, P = .01, respectively). However, the mitomycin C group had a significantly higher incidence of prolonged hypotony (intraocular pressure less than 6 mm Hg) compared with the control group (15% vs 0% at nine months, P = .05). Younger age was associated with a higher incidence of persistent hypotony. CONCLUSIONS: Adjunctive subconjunctival mitomycin C (0.5 mg/ml for a three-minute exposure) in primary trabeculectomies of phakic eyes, while increasing the success rate by decreasing intraocular pressure and postoperative medications, is associated with a higher incidence of prolonged hypotony.

Adult↗

PubMed1990

Adjunctive use of delayed and adjustable low-dose 5-fluorouracil in refractory glaucoma.

We used delayed 5-mg subconjunctival injections of 5-fluorouracil as an adjunct to filtering surgery in ten eyes with refractory glaucoma. The first 5-fluorouracil injection was made three to 15 days postoperatively and was used only when clinical signs suggested an impending bleb failure. These signs included flattening and localization of bleb, increased vascularity, early subconjunctival scarring, loss of microcystic conjunctival changes, and increased intraocular pressure. After a follow-up of ten to 17 months (mean, 13.7 months), an intraocular pressure of less than 21 mm Hg was attained in five eyes without medication and in four eyes with medication. The treatment failed in one eye. The average dose of 5-fluorouracil was 28 +/- 12 mg per eye. There were no conjunctival wound leaks. Six eyes developed transient corneal epithelial defects. The modified administration of 5-fluorouracil can result in fewer conjunctival wound leaks. Its use can be limited to those patients who show evidence of impending bleb failure.

Adolescent↗

PubMed1981

Treatment of congenital glaucoma.

We reviewed 37 consecutive patients who had undergone at least one goniotomy, filtering surgery, and patching for amblyopia because of congenital glaucoma between 1969 and 1979. Of 32 eyes treated for uncomplicated congenital glaucoma, 25 (78%) achieved satisfactory control of intraocular pressure. Seven of the 12 eyes (58%) for which Snellen visual acuities could be obtained had visual acuities of 6/15 (20/50) or better. Of eight eyes treated for complicated congenital glaucoma, four (50%) achieved satisfactory control of intraocular pressure, but the visual acuities of these patients could not be tested.

Acetazolamide↗

PubMed2000

Vitrectomy for the Treatment of Expulsive Hemorrhage.

Purpose: An evaluation of surgical outcome of vitrectomy in the treatment of expulsive hemorrhage associated with intraocular surgery.Methods: We reviewed 12 eyes from 12 patients with expulsive hemorrhage, occurring after or during cataract extraction (4 eyes), phacoemulsification (2 eyes), glaucoma filtering surgery (4 eyes), or vitrectomy (2 eyes). Mean follow-up period was 21 months.Results: The retina was reattached in 6 eyes (50%) after the initial surgery and ultimately in 9 eyes (75%). Three eyes, which failed to achieve retinal reattachment, resulted in phthisis bulbi. Final visual acuity was 0.1 or better in 4 eyes and 0.01 to 0.09 in 4 eyes. The incidence of expulsive hemorrhage was 0% for cataract surgery, 0.57% for trabeculectomy, and 0.09% for vitrectomy at Toho University Sakura Hospital.Conclusion: In the treatment of expulsive hemorrhage, vitrectomy is an effective surgical procedure to improve the visual function.

Journal Article↗

PubMedDate not supplied

Synthesis and characterization of self-catalyzed poly(ortho ester).

Poly(ortho esters) are currently under investigation as a carrier system for an antiproliferative agent in glaucoma filtering surgery. The present investigation illustrates the development of a series of self-catalyzed poly(ortho ester). These polymers contain short dimer segments of alpha-hydroxy acids in their backbone and are prepared by the addition of different polyols to the diketene acetal 3,9-diethylidene-2,4,8,10-tetra-oxaspiro-[5.5]-undecane. The structures were confirmed by NMR- and FT-IR-spectroscopy. The polymers were characterized by determination of the molecular weight, the glass transition temperature and the rheological behavior. The amount of residual solvents was also analyzed. The characteristics of the polymer can be varied by the type of polyol incorporated in its backbone. Since poly(ortho ester) is susceptible to acid-catalyzed degradation, the polymer hydrolysis can be controlled by the amount of incorporated portion of alpha-hydroxy acid. Due to the high hydrophobicity of the polymer structure, the ester bonds are more susceptible to hydrolysis than the ortho ester bonds in the polymer backbone. The hydrolysis proceeds via initial protonation of the exocyclic alkoxy group to yield pentaerythritol dipropionate and the free diol. In a next step, the pentaerythritol dipropionate hydrolysis to pentaerythritol and propionic acid. The molecular weight decrease, weight loss and the pH profile of the polymer in aqueous medium were monitored during the degradation.

Antineoplastic Agents↗

PubMed2001

Quality of life in newly diagnosed glaucoma patients : The Collaborative Initial Glaucoma Treatment Study.

OBJECTIVE: The Collaborative Initial Glaucoma Treatment Study (CIGTS) was designed to determine whether patients with newly diagnosed open-angle glaucoma are better treated initially by medicine or immediate filtering surgery. This paper describes the quality-of-life (QOL) measurement approach, instruments included, and the CIGTS participants' QOL findings at the time of diagnosis. DESIGN: Baseline results from a randomized, controlled clinical trial. PARTICIPANTS: Six hundred seven patients from 14 clinical centers were enrolled. INTERVENTION: Patients randomized to initial medication received a stepped medical regimen (n = 307). Those randomized to initial surgery underwent a trabeculectomy (n = 300). The baseline interview was conducted before treatment initiation. All baseline and posttreatment QOL assessments were conducted by telephone from a centralized interviewing center. MAIN OUTCOME MEASURES: The primary outcome measure described in this paper was QOL. The QOL instrument is multidimensional and incorporates both disease-specific and generic measures, including the Visual Activities Questionnaire, Sickness Impact Profile, and a Symptom and Health Problem CHECKLIST: RESULTS: The correlations between QOL measures and clinical outcomes were in the expected direction, but relatively weak. At initial diagnosis, difficulty with bright lights and with light and dark adaptation were the most frequently reported symptoms related to visual function, whereas visual distortion was the most bothersome. Approximately half of the patients reported at least some worry or concern about the possibility of blindness. Within the Visual Activities Questionnaire, higher scores on the Peripheral Vision subscale were associated with more field loss (P < 0.01). In regression analyses controlling for sociodemographics and nonocular comorbidities, increased visual field loss was significantly associated with higher dysfunction among five disease-specific QOL measures (P < 0.05). CONCLUSIONS: Newly diagnosed glaucoma patients reported experiencing some visual function symptoms at the time of diagnosis that would not be intuitively expected based on clinical testing. Some discussion about the association between clinical presentation and worry about blindness may reduce unnecessary concern. These results provide the basis for long-term comparisons of the QOL effects of initial medical and surgical treatment for open-angle glaucoma.

Adult↗

PubMed2002

Randomized controlled clinical trial of beta irradiation as an adjunct to trabeculectomy in open-angle glaucoma.

OBJECTIVE: To assess the effect of a single intraoperative application of 750 cGy of beta irradiation on the outcome of trabeculectomy for uncontrolled open-angle glaucoma. DESIGN: A prospective, randomized, double-blind, placebo-controlled clinical trial. PARTICIPANTS: Sixty-one eyes of 61 Caucasian patients at low risk of filtering surgery failure, with poorly controlled primary or secondary open-angle glaucoma undergoing routine trabeculectomy. METHOD: Patients were randomly assigned to control or beta irradiation groups. All patients underwent standard trabeculectomy with fornix-based conjunctival incision. Eyes assigned to beta irradiation received 750 cGy of beta irradiation directly over the sclerostomy site on completion of conjunctival suturing. An identical but inactive applicator was applied to control eyes, delivering no radiation. Both operator and patient remained masked to the assignment for the 12-month follow-up period. MAIN OUTCOME MEASURES: The main outcome measure was intraocular pressure (IOP) control. Complete success of IOP control was defined as an IOP less than 21 mmHg at 12 months without need for additional medication. Qualified success was defined as an IOP less than 21 mmHg at 12 months where additional medication was required. RESULTS: Complete success of IOP control was achieved in 19 (86%) control eyes and 35 (90%) irradiated eyes (P = 1.0). Qualified success of IOP control was achieved in 21 (95%) control eyes and 39 (100%) irradiated eyes at 12 months follow-up (P = 1.0) CONCLUSIONS: We experienced a very high success rate of filtration surgery in this select population without adjunctive irradiation. Our sample size was too small to show any improvement in success with use of beta irradiation in this group. Other studies would have to be done to determine whether it may have measurable benefit in cases with a high risk of filtration failure.

Aged↗

PubMed2002

Chronic angle-closure with glaucomatous damage: long-term clinical course in a North American population and comparison with an Asian population.

PURPOSE: To study the long-term clinical course of North American chronic angle-closure glaucoma (CACG) patients with optic disc damage and visual field loss in the presence of an angle closed at least partially by peripheral anterior synechiae and to compare it with a similar group of Singaporean patients. DESIGN: A retrospective, interventional case-control study series. PARTICIPANTS: Fifty-one patients (80 eyes) diagnosed with CACG with glaucomatous optic nerve head and visual field damage at a New York hospital from January 1990 through December 1994. All study eyes underwent laser peripheral iridotomy (LPI). METHODS: The presenting features, management, and subsequent long-term intraocular pressure (IOP) outcome were analyzed and compared with 65 Asian patients (83 eyes) from a Singapore hospital who were similarly diagnosed during the same period. MAIN OUTCOME MEASURES: The long-term outcome after LPI was assessed in terms of IOP and the requirement for additional therapy. RESULTS: The mean presenting IOP was higher in the Singapore eyes (40 +/- 15 mmHg) compared with the New York eyes (31 +/- 12.5 mmHg). All 80 New York eyes (100%) and 78 of 83 Singapore eyes (94%) required further treatment to control IOP during follow-up. Of the eyes with a subsequent rise in IOP, 33 of 80 eyes (41.3%) compared with 34 of 83 eyes (41.0%) of the Singapore patients were controlled with additional topical medication. Of the New York eyes, 25 of 80 (31.3%) eventually underwent filtering surgery, compared with 44 of 83 (53.0%) in the Singapore study. The other 22 eyes (27.5%) in the New York group went on to additional laser procedures, peripheral iridoplasty, laser trabeculoplasty, or a combination thereof, after which IOPs were controlled and no surgery was required. There was no similar comparison for the Singapore group, because these eyes went directly on to surgery. CONCLUSIONS: Despite the presence of a patent LPI, most eyes with CACG presenting with elevated IOP and having both optic disc and visual field damage in both populations required further treatment to control IOP. Results in the American population are similar to that reported in Asian patients.

Aged↗

PubMed2003

Risk factors for hypotony maculopathy.

PURPOSE: To determine the risk factors for hypotony maculopathy. DESIGN: Retrospective case control study. PARTICIPANTS: Two hundred twenty-eight eyes of 228 patients with hypotony from one medical center. METHODS: Chart review of patients with hypotony from January 1988 to April 2001. Hypotony was defined as intraocular pressure of 5 mmHg or less. Cases of hypotony maculopathy had retinal or choroidal folds or both within the arcades. Controls had hypotony alone. Risk factors were evaluated using multiple logistic regression analysis. MAIN OUTCOME MEASURES: Risk factors for hypotony maculopathy, including age, gender, race, refractive error, systemic illness, intraocular pressure, primary filtering surgery, use of antifibrotic agents, and presence of choroidal effusion. RESULTS: Eighty-one case eyes with hypotony maculopathy and 147 control eyes with hypotony alone were identified. The mean age of patients with hypotony maculopathy was 50.5 years +/- 18.7 compared with 70.6 years +/- 12.7 for the control patients (P < 0.001). More patients with hypotony maculopathy were male, 54.3% (44 of 81), than controls, 33.6% (49 of 147) (P = 0.004). The refractive error was -3.02 +/- 3.67 diopters (D) for phakic eyes with hypotony maculopathy (n = 31), whereas the phakic control eyes' (n = 30) refractive error was -0.61 D +/- 2.00 (P = 0.003). Choroidal effusion was found in 21% (17 of 81) of the case eyes at diagnosis and 52.4% (77 of 147) of the control eyes (P < 0.001). Race distribution and use of antifibrotics was similar for both groups. In multivariate analyses, young age, male gender, no history of diabetes, and absence of choroidal effusion predicted the development of hypotony maculopathy; in phakic eyes myopia was also a risk factor for hypotony maculopathy. CONCLUSIONS: Young age, male gender, and myopia are significant risk factors for hypotony maculopathy. A history of diabetes and the presence of choroidal effusion are associated with a decreased risk for hypotony maculopathy.

Age Factors↗

PubMed1982

Filtering valve implant for neovascular glaucoma in proliferative diabetic retinopathy.

The prevention and treatment of neovascular glaucoma in diabetic patients presents a difficult clinical challenge. This report presents the pathologic findings in a juvenile onset diabetic patient who underwent panretinal photocoagulation. She subsequently developed neovascular glaucoma, was treated with the the Krupin-Denver valve implant, and received cyclocryotherapy after the filtering surgery failed to maintain a normal intraocular pressure. The pathologic findings resulting from each treatment modality are presented with emphasis on the failed intraocular valve. A fibrous ingrowth surrounded the valve, and a foreign body granulomatous response was present.

Adult↗

PubMed1987

Pars plana vitrectomy for vitreous amyloidosis.

Thirty-six pars plana vitrectomies were performed on 30 eyes of 17 patients with biopsy-proven vitreous amyloidosis. Reopacification of the retrolental vitreous was the most common reason for vitrectomy revision, required in 24% of patients. Complications of amyloid or vitrectomy included retinal detachment requiring scleral buckling in 17% of eyes and glaucoma requiring filtering surgery in 17% of eyes. After a mean 35-month post-vitrectomy follow-up, 48% of eyes had visual acuities of 20/40 or better, and 32% of eyes had visual acuities between 20/50 and 20/100. Twenty percent of eyes had visual acuities of 20/200 or worse due either to persistent retinal detachment, open angle glaucoma, or residual opacification of the vitreous.

Amyloidosis↗

PubMed1988

Medical management of a high bleb phase after trabeculectomies.

In the first 2 months after trabeculectomy, elevated intraocular pressure (IOP) associated with a high bleb develops in some patients. This has been referred to as an encysted bleb, and some have recommended surgical techniques to repair it and to restore controlled IOP. This clinical picture occurred in 18 of 181 eyes (10%) undergoing simple trabeculectomy with a limbus-based conjunctival flap and tenonectomy. It did not occur among 69 eyes in which trabeculectomy with a fornix-based flap was combined with extracapsular cataract extraction (ECCE). Its occurrence may, therefore, be related to surgical technique. In eyes with this syndrome, the authors used IOP-lowering eyedrops and/or pills, along with continued corticosteroid eyedrops. None required surgical manipulation. All 18 eyes achieved long-term IOP control, and in 14 all medications were ultimately discontinued. An hypothesis is suggested to explain the occurrence of this event and the rationale for this therapy. A trial of IOP-lowering treatment is indicated in the management of a high bleb phase after filtering surgery.

Adolescent↗

PubMed1989

A new modified vitreoretinal surgical approach in the management of massive suprachoroidal hemorrhage.

The authors describe a new surgical approach used in six consecutive patients referred to us between August 1986 and August 1988 with massive suprachoroidal hemorrhage (MSCH) during or after cataract extraction (4 patients), glaucoma filtering surgery (1 patient), or scleral buckling (1 patient). All patients had large hemorrhagic choroidal detachments with five eyes showing "kissing" detachments. Secondary surgery was delayed 7 to 25 days (mean, 14 days) to allow liquefaction of the blood clot and reduce intraocular inflammation. All eyes underwent posterior drainage sclerotomies under constantly maintained limbal fluid infusion line pressure, followed by pars plana anterior and posterior vitrectomy in five of six eyes. Additionally, two eyes underwent secondary lens implantation during surgery and 6 months later, respectively. Mean follow-up was 10 months. Visual acuity improved in all eyes from a preoperative range of light perception-hand motions to hand motions-20/40. Advantages and disadvantages of this aggressive surgical approach in the management of MSCH are discussed.

Aged↗

PubMed1989

Risk factors for the development of Tenon's capsule cysts after trabeculectomy.

Tenon's capsule cysts (TCCs) are a complication of glaucoma filtering surgery. They are frequently associated with substantial elevations in intraocular pressure (IOP) beginning 2 to 8 weeks postoperatively. To determine the incidence and possible risk factors for the development of TCCs, case records of all patients who received trabeculectomy over a 4-year period at the Wills Eye Hospital were reviewed. The incidence of TCCs was 28% in those who underwent trabeculectomy. Characteristics of patients after trabeculectomy in whom TCCs developed were compared with patients after trabeculectomy in whom TCCs did not develop. Both univariate and multivariate techniques were used to assess the association of characteristics associated with the development of TCCs. Factors associated with increased risk (P less than 0.05) were: history of prior TCCs, argon laser trabeculoplasty, male gender, and the use of preoperative sympathomimetics. The use of a compression shell was associated with decreased risk (P less than 0.05).

Adult↗

PubMed1990

Effects of topical glaucoma drugs on fistulized rabbit conjunctiva.

Conjunctival fibroblastic proliferation with contracting scar formation has been implicated as a possible cause of glaucoma filtering surgery failure. The effects of glaucoma medications on bulbar conjunctiva were evaluated in both eyes of 20 pigmented rabbits, with 5 rabbits per group each receiving singular topically applied daily doses of either 0.5% timolol, 1% epinephrine, 4% pilocarpine, or artificial tears in a masked fashion for 4 months. Posterior lip sclerectomies were performed in 16 rabbits--4 from each treatment group. The remaining four rabbits served as nonsurgical controls. Four additional rabbits, which had not received eye drops, were included as a nonmedicated control group, with one rabbit serving as a nonsurgical control. Immunostaining was performed to identify the presence of myofibroblasts in fistulized conjunctiva. Treated surgical eyes, regardless of medication, had higher myofibroblastic cell proliferation than treated nonsurgical eyes. Among fistulized eyes, all medications increased cell proliferation, with pilocarpine eliciting the most dramatic increase compared with all other groups.

Animals↗