Risto J. Uusitalo

Evaluating cataract surgery gains by assessing patients' quality of life using the VF-7.

PURPOSEnTo describe the development and performance of a questionnaire designed to measure functional impairment caused by cataract.nnnSETTINGnDepartment of Ophthalmology, Helsinki University Central Hospital, Helsinki, Finland.nnnMETHODSnThe results of a visual-functioning index (VF-14) of 168 patients with first-eye cataract surgery were analyzed. Patients with significant comorbidity were excluded, leaving 142 patients for the final analysis. Snellen visual acuity measurements and complete preoperative and 4 month postoperative clinical status were performed by ophthalmologists. Outcome measures, including the VF-14, patient perception of trouble with vision, patient satisfaction with vision, and the cataract symptom score, were taken by nurses at the preoperative clinical examinations and at the 4 month postoperative visit. The Spearman rank correlation was used to determine which items of the VF-14 best correlated with a change in patient satisfaction.nnnRESULTSnSeven items of the VF-14 that best correlated with patient satisfaction were selected for inclusion in a new 7-item index (the VF-7). Based on the Spearman rank correlation, the items from best to worst were nighttime driving; reading small print; watching television; seeing steps, stairs, or curbs; reading traffic, street, or store signs; cooking; and doing fine handwork. The correlation among changes in the VF-7 score and visual acuity in the operated eye was 0.17, while the correlation among changes in the VF-7 and patient satisfaction caused by cataract surgery was high (r = .56).nnnCONCLUSIONnThe VF-7 was a strong predictor of change in patient satisfaction caused by cataract surgery.

Intraocular pressure after phacoemulsification and intraocular lens implantation in nonglaucomatous eyes with and without exfoliation.

Purpose: To evaluate intraocular pressure (IOP) after phacoemulsification and intraocular lens (IOL) implantation in nonglaucomatous eyes with and without exfoliation. Setting: Department of Ophthalmology, Helsinki University Central Hospital, Helsinki, Finland. Methods: One hundred ninety‐six eyes that had phacoemulsification with IOL implantation were examined. Eyes with a history of intraocular disease or surgery that could affect IOP were excluded. The study comprised the remaining 160 eyes: 23 with exfoliation (EXF group) and 137 without exfoliation (non‐EXF group). Follow‐up data were available for 136 eyes. The same surgeon performed all surgeries. Patients were examined on the first postoperative day and after 1 week, 4 months, and 1.0 to 2.7 years. Results: One day postoperatively, IOP rose in the EXF group from a mean preoperative level of 16.3 mm Hg ± 2.7 (SD) to 21.0 ± 8.5 mm Hg, a 28.4% increase (P = .0061). In the non‐EXF group, mean IOP rose from 16.2 ± 3.4 mm Hg to 20.5 ± 5.7 mm Hg, a 29.9% increase (P = .001). In 4 eyes (17.4%) in the EXF group and 8 eyes (5.8%) in the non‐EXF group, IOP increased to 30 mm Hg or higher at 1 day. After this, significant IOP decreases occurred in both the EXF and non‐EXF group, respectively, as follows: 14.2 ± 3.0 mm Hg (12.0% decrease from preoperative value; P = .001) and 15.0 ± 2.9 mm Hg (5.9%; P = .001) 1 week postoperatively; 12.8 ± 2.7 mm Hg (20.2%; P = .0002) and 13.8 ± 2.7 mm Hg (13.2%; P = .001) after 4 months; and 12.3 ± 2.6 mm Hg (23.2%; P = .0001) and 12.7 ± 2.7 mm Hg (21.2%; P = .001) after 1.0 to 2.7 years. There was no significant difference between the 2 groups. Conclusion: After phacoemulsification with IOL implantation, IOP decreased significantly and remained lower than preoperatively in eyes with and without exfoliation. One day postoperatively, transient pressure peaks were more common in eyes with exfoliation. One eye without exfoliation developed glaucoma.

Simultaneous bilateral cataract surgery: economic analysis; Helsinki Simultaneous Bilateral Cataract Surgery Study Report 2.

PURPOSE: To present an economic‐analysis comparison of simultaneous and sequential bilateral cataract surgery. SETTING: Helsinki University Eye Hospital, Helsinki, Finland. DESIGN: Economic analysis. METHODS: Effects were estimated from data in a study in which patients were randomized to have bilateral cataract surgery on the same day (study group) or sequentially (control group). The main clinical outcomes were corrected distance visual acuity, refraction, complications, Visual Function Index‐7 (VF‐7) scores, and patient‐rated satisfaction with vision. Health‐care costs of surgeries and preoperative and postoperative visits were estimated, including the cost of staff, equipment, material, floor space, overhead, and complications. The data were obtained from staff measurements, questionnaires, internal hospital records, and accountancy. Non‐health‐care costs of travel, home care, and time were estimated based on questionnaires from a random subset of patients. The main economic outcome measures were cost per VF‐7 score unit change and cost per patient in simultaneous versus sequential surgery. RESULTS: The study comprised 520 patients (241 patients included non‐health‐care and time cost analyses). Surgical outcomes and patient satisfaction were similar in both groups. Simultaneous cataract surgery saved 449 Euros (&U20AC;) per patient in health‐care costs and &U20AC;739 when travel and paid home‐care costs were included. The savings added up to &U20AC;849 per patient when the cost of lost working time was included. CONCLUSION: Compared with sequential bilateral cataract surgery, simultaneous bilateral cataract surgery provided comparable clinical outcomes with substantial savings in health‐care and non‐health‐care–related costs. Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned.

Topical anesthesia with or without propofol sedation versus retrobulbar/ peribulbar anesthesia for cataract extraction Prospective randomized trial

Purpose: To evaluate the feasibility of intravenous sedation in addition to topical anesthesia during cataract extraction. Setting: Helsinki University Eye Hospital, Helsinki, Finland. Methods: Three hundred seventeen eyes of 291 consecutive patients having cataract surgery were prospectively randomized to receive topical (oxybuprocaine 0.4%, n = 96), combined (topical anesthesia and propofol sedation, n = 107), or retrobulbar/peribulbar (prilocaine 1.5%, n = 114) anesthesia. The intraoperative conditions were judged by the surgeon. A numerical scale (0 to 10) was used to assess the degree of pain during surgery. Outcome measures were the number of complications and adverse events registered perioperatively and 1 week postoperatively as well as Snellen visual acuity. Results: The success of posterior chamber intraocular lens (IOL) implantation through a self‐sealing clear corneal incision was 97.9%, 96.3%, and 98.2% in the topical, combined, and retrobulbar/peribulbar groups, respectively. There was no difference among the groups in pain during surgery, frequency of complications, or outcome measures. One week postoperatively, visual acuity was 20/40 or better in 81.7%, 78.5%, and 77.5% of eyes in the topical, combined, and retrobulbar/peribulbar groups, respectively. The surgeon reported significantly fewer difficulties in the retrobulbar/peribulbar group (9.8%) than in the topical (26.0%) (P = .004) or combined (21.0%) (P = .036) groups. Additional sedative/analgesic medication given intraoperatively was required significantly more often in the topical (15.6%) than in the retrobulbar/peribulbar group (2.6%) (P = .002). Patients with bilateral surgery preferred combined anesthesia over retrobulbar/peribulbar anesthesia; however, there was no significant difference in patient acceptance among groups in patients having unilateral surgery. Conclusion: Intravenous propofol sedation added to topical anesthesia did not improve the operative conditions or surgical outcome. Retrobulbar/peribulbar anesthesia ensured the best surgical conditions. Patients in all anesthesia groups reported high satisfaction. However, patients having bilateral surgery seemed to prefer combined anesthesia over retrobulbar/peribulbar anesthesia.

Outcomes of small incision cataract surgery

Purpose: To compare cataract surgery outcome measures 4 months postoperatively and determine their association with changes in the eye’s functional state. Setting: Department of Ophthalmology, Helsinki University Central Hospital, Finland. Methods: This longitudinal study comprised 219 consecutive patients having first‐eye or second‐eye cataract surgery by one surgeon. In most patients, the technique consisted of small‐incision cataract surgery with in‐the‐bag intraocular lens implantation. Patients were interviewed and clinical data obtained preoperatively and 4 months postoperatively. Adverse events occurring within 24 hours and 4 months postoperatively were compared with changes in global measures of vision. Surgical success in terms of surgically induced astigmatism (SIA) was measured at 4 months using vector analysis of the changes in astigmatism and defining the extent to which the surgical goal was achieved. The association between the surgical astigmatism goals and global measures of vision was analyzed. Results: The percentage of patients showing improvement 4 months after first‐eye cataract surgery varied by outcome measure: Snellen visual acuity (95.0%), VF‐14 score (89.4%), satisfaction with vision (80.1%), self‐reported trouble with vision (75.8%), and cataract symptoms (75.1%). Changes in Snellen acuity after secondeye cataract surgery were similar but VF‐14 changes were significantly less than after first‐eye surgery. Changes in global measures of vision were also better after first‐eye surgery. The correlation between the change in VF‐14 score and global measures of vision was stronger than between the change in Snellen acuity and the same general outcome measures. A good correlation was also seen between the changes in VF‐14 scores and cataract symptoms. Mean SIA in all eyes was 0.2 diopter (D) ± 0.7 (SD); 91.2% were within ±1.0 D of preoperative values. Failure to achieve surgical astigmatism goals was not associated with patients in whom global measures of vision did not improve, nor was there a correlation between adverse events occurring within 24 hours or 4 months postoperatively and global measures of vision. The only association was between ocular comorbidity or potential risk factors of phacoemulsification and adverse events seen within 24 hours and at 4 months. Conclusion: Estimates of the proportion of patients benefiting from cataract surgery varied with the outcome measure used to determine benefit. The change in the VF‐14 score was a better measure than Snellen acuity of the benefit of cataract surgery.

Converting to topical anesthesia in cataract surgery.

PURPOSEnTo evaluate the complications and difficulties encountered by surgeons converting from paraocular to topical anesthesia in cataract surgery and to evaluate patient pain and satisfaction with each procedure.nnnSETTINGnDepartment of Ophthalmology, Helsinki University Central Hospital, Helsinki, Finland.nnnMETHODSnThree hundred eyes of 245 consecutive patients were prospectively assigned by permuted block-restricted randomization to receive topical (bupivacaine 0.75%) (Group 1; n = 136) or paraocular (Group 2; n = 163) anesthesia. The intraoperative conditions were judged by the surgeon. A numerical scale (0 to 10) was used to assess the degree of pain during administration of anesthesia, during surgery, and 1 and 24 hours postoperatively. Outcome measures were the number of complications and adverse events registered perioperatively and 4 months postoperatively as well as Snellen visual acuity and surgically induced astigmatism (SIA) measured 1 week and 4 months after surgery.nnnRESULTSnThe success of posterior chamber intraocular lens (IOL) implantation through a self-sealing clear corneal incision was very high (99.3% and 96.9% in Groups 1 and 2, respectively). One case (0.7%) in the topical group required vitrectomy and implantation of an anterior chamber IOL. Anesthesia-related difficulties were reported in about 40% of patients in Group 1 and 4% in Group 2 (P < .001). Supplemental paraocular anesthesia was required in 4 cases (2.9%) in the topical group. Sedative/analgesic medication given perioperatively was required significantly more often in Group 1 (13.2%) than in Group 2 (2.4%) (P < .01). Significantly more pain during surgery (P < .001) and 1 hour after surgery (P < .001) was reported in the topical group. In Group 1 69.9% and in Group 2 93.3% reported no pain during surgery (P < .001). Chemosis (1.8%), subconjunctival hemorrhage (1.2%), and periorbital hematoma (1.2%) were seen only in the paraocular group. Perioperatively, no severe complications occurred in Group 1 and the number of adverse events was less than in Group 2. Postoperatively, 2 cases of endophthalmitis developed in the topical group and none in the paraocular group. There was no between-group difference in outcome measures; a visual acuity of 20/40 or better was found in 87.8% of eyes in Group 1 and 84.9% in Group 2 4 months postoperatively, and the percentages of eyes with SIAs within 1.0 diopter of preoperative values were similar (78.6% and 73.3%, respectively). Patient preference for topical anesthesia appeared to be higher than for paraocular anesthesia.nnnCONCLUSIONnParaocular anesthesia gave better analgesia than topical, but topical anesthesia provided acceptable analgesia during surgery and showed that intraocular procedures can be performed without akinesia. The surgeon converting to topical anesthesia may expect slight difficulty in 40% of cases and more severe difficulty in 7%. Surgically related complications were similar with both methods.

Simultaneous bilateral versus sequential bilateral cataract surgery: Helsinki Simultaneous Bilateral Cataract Surgery Study Report 1

PURPOSE: To evaluate the refractive outcomes, complication rates, and changes in patients functional state and satisfaction with simultaneous compared with sequential bilateral cataract surgery. SETTING: Helsinki University Eye Hospital, Helsinki, Finland. DESIGN: Clinical trial. METHODS: Consecutive patients scheduled for bilateral cataract surgery were enrolled based on appropriate inclusion criteria and randomized to be operated on in 1 session (study group) or sequentially (control group) 4 to 6 weeks apart. RESULTS: Four hundred ninety‐one (94.4%) of the 520 patients completed the study. Of the eyes, 493 (247 patients) had bilateral surgery in 1 session and 506 (257 patients) in separate sessions. In the study group, 240 patients (96.0%) were treated per protocol. In the control group, 250 patients (97.3%) were treated per protocol. The refraction was within ±0.50 diopter (D) of the target in 67.2% of eyes in the study group and 69.2% of eyes in the control group and within ±1.00 D in 91.0% and 90.3%, respectively (P=.92). The only complication that affected postoperative visual acuity was chronic cystoid macular edema, which occurred in 1 eye in the study group (0.2%) and in 2 eyes (0.4%) of 1 patient in the control group (P=.57). Ninety‐five percent of patients in both groups reported being very satisfied with surgery. CONCLUSION: The refractive outcomes, rates of complications, and patient‐rated satisfaction were similar whether bilateral cataract surgery was performed simultaneously or sequentially. Financial disclosure: No author has a financial or proprietary interest in any material or method mentioned.

Long-term evaluation of timolol.

Abstract. Maintenance effect of the topical beta‐blocker timolol on intraocular pressure (IOP) was investigated for a mean follow‐up of 31.6 months in a group of 155 patients (275 eyes) with glaucoma or ocular hypertension. The mean IOP‐value was calculated from 3 readings of the daytime IOP curve, and the mean eye pressure of the right and left eye in the respective individual was used. The medical therapy was carried out with our ranking order of drugs of choice: timolol, timolol combined with adjunctive drug therapy, laser trabeculoplasty and/or filtering surgery. Intraocular pressure was controlled with timolol alone in 98 of 155 patients (63.2%, Group 1). In 36 patients, timolol plus adjunctive medication was required to control IOP (23.2%, Group 2). Twenty‐one (13.6%, Group 3) required either laser trabeculoplasty or filtering surgery in addition to timolol. Sufficient IOP‐lowering effect was more frequently maintained in patients with ocular hypertension than those with glaucoma simplex or capsular glaucoma. Failures in timolol treatment occurred mostly within 6 months from the start of the therapy and correlated well with higher initial IOP. Transient adverse effects were observed in 11.2% of cases. In three cases (1.9%) local and systemic side effects were serious enough to require discontinuation of the drug therapy. One patient (0.7%) was a non‐responder and was withdrawn from the study for that reason. Sixteen patients (10.3%) were lost to follow‐up during the 4 year study.

Irradiation cataract in children after bone marrow transplantation

Chemotherapy and radiation produce a dose-dependent anti-leukemic effect. Combined chemoradiotherapy and bone marrow transplantation (BMT) were given in our clinic to treat children with acute leukemias. Total body irradiation of 10 Gy in a single dose was used. One long-term side effect of this treatment was the development of subcapsular cataract; this was seen in all nine long-term survivors of the 17 children with acute lymphoblastic (ALL) or acute myelogenous (AML) leukemia who were treated as described above. One year after marrow transplantation, all the eyes studied had visual acuity of 20/20 and an optically clear lens. Three years later, 60% of the eyes had visual acuity of less than 20/40 and all had posterior, subcapsular cataracts. The cataract in all cases was quite uniform, consisting of opacities in the posterior subcapsular region. Cataract formation was treatment-related and seemed to correlate only to the type of total body irradiation. We concluded that the cataracts seen in the present study were a late complication of allogeneic BMT and were specifically due to the single-dose total body irradiation.

Prevention of experimental corneal allograft rejection in rabbits using cyclosporin-collagen shields

Topical administration of cyclosporin A, a highly hydrophobic cyclic undecapeptide, has been relatively ineffective in preventing corneal allograft rejections due to poor drug penetration. Therefore, we investigated a new continuous-delivery system for cyclosporin A using collagen bandage shields fabricated from porcine scleral tissue. Collagen bandage shields containing 4 mg cyclosporin A were used for the treatment of four corneal allografts embedded in prevascularized rabbit corneas. Four controls were treated with shields containing no cyclosporin A. The shields were changed every 2nd day and signs of rejection were recorded. All controls were rejected by the end of the experiment. Treatment with collagen shields containing cyclosporin A effectively prevented such rejection. The clinical examinations were also confirmed with histopathological analysis. The results indicate that collagen shields can slowly release cyclosporin A and increase the penetration time for the drug. Thus, they are excellent delivery systems for hydrophobic drugs with poor penetration properties.