The study protocol adhered to the tenets of the Declaration of Helsinki. Approval for the trial was taken from the local Ethics Committee and all the participants signed a written informed consent. A total of 80 eyes of 76 patients were investigated in this study.
All eyes that underwent TSV between January 2009 to December 2010, for macular hole, epiretinal membrane, vitreomacular traction, and vitreous hemorrhage with attached retina on a USG B-scan, were included in the study. Cases having retinal detachments, those that required port conversion and suturing of port, re-surgery, pre-existing uveitis, those who had received intravitreal triamcinolone or anti vascular endothelial growth factor (VEGF) injections within three months of surgery, and cases requiring silicone oil for tamponade or buckling were excluded. Patients requiring cataract surgery along with vitrectomy were also excluded.
The participants were randomized to the postoperative topical nepafenac (0.1%) group or topical prednisolone acetate (1%) group in a double-masked fashion by a computer-generated randomization schedule. Cases receiving nepafenac formed Group 1 (n = 40) and cases receiving topical prednisolone acetate formed Group 2 (n = 40).
All cases were operated on the Alcon constellation vision system by the same surgeon (M.N). All cases completed the three-month follow up. The subjects were asked to grade the ocular pain on the visual analog scale.[17 (link)18 (link)] The VAS consisted of a 10-cm line, with 0 on one end representing no pain and 10 on the other representing the worst pain ever experienced. A subject marked on this line to indicate the severity of his or her pain experience. The VAS was filled up by the patients on Day 1, Day 30, and Day 90. Intraocular inflammation was graded on each visit by an investigator, masked to the study group (S.L.), using the Standardization of Uveitis Nomenclature Working Group grading classification. According to this classification, less than one cell (in a 1 mm2 field illuminating the anterior chamber) is taken as grade 0, 1 to 5 cells as grade 0.5, 6 to 15 cells grade 1, 16 to 25 cells as grade 2, 26 to 50 cells as grade 3, and more than 50 cells as grade 4. Lid edema was graded as follows: Minimal swelling with lid creases visible was grade 1, moderate swelling with skin creases affected was grade 2, marked swelling when eye lids could be opened actively was grade 3, and extreme swelling when eyelids could not be opened actively was grade 4. Conjunctival chemosis was taken as grade 1 if it involved 30% of the conjunctiva, grade 2 if it involved 30-70% of the conjunctiva, and grade 3 if it involved 70-100% of the conjunctiva. Conjunctival hyperemia was graded as grade 0 for no hyperemia, grade 1 for sectoral engorgement of vessels, grade 2 for diffuse engorgement, and grade 3 for significant engorgement.
Best corrected visual acuity was obtained on Snellen Visual acuity charts at each visit.
Subjects self-administered the drops in both the groups, with group 1 receiving nepafenac (Nevanac, Alcon Laboratories, Inc. Fort Worth, Texas, USA) three times in a day for six weeks and group 2 receiving Pred Forte (Allergan, Inc. Irvine, CA, U.S.A.) beginning six times a day for week one and four times a day till week four, two times a day for week five, and once a day for week six. All the patients received prophylactic antibiotics for four weeks and atropine sulfate 1% HS for a week. All the patients also received a diclofenac sodium 100 mg suppository preoperatively and diclofenac sodium 50 mg tablet postoperatively twice per day, for five days.
The descriptive statistics were calculated for case characteristics. Group comparisons were performed with the Wilcoxon rank-sum test, using the two-sided analysis. P < 0.05 was considered significant. Snellen visual acuity was converted to logMAR units for analysis purposes.
All eyes that underwent TSV between January 2009 to December 2010, for macular hole, epiretinal membrane, vitreomacular traction, and vitreous hemorrhage with attached retina on a USG B-scan, were included in the study. Cases having retinal detachments, those that required port conversion and suturing of port, re-surgery, pre-existing uveitis, those who had received intravitreal triamcinolone or anti vascular endothelial growth factor (VEGF) injections within three months of surgery, and cases requiring silicone oil for tamponade or buckling were excluded. Patients requiring cataract surgery along with vitrectomy were also excluded.
The participants were randomized to the postoperative topical nepafenac (0.1%) group or topical prednisolone acetate (1%) group in a double-masked fashion by a computer-generated randomization schedule. Cases receiving nepafenac formed Group 1 (n = 40) and cases receiving topical prednisolone acetate formed Group 2 (n = 40).
All cases were operated on the Alcon constellation vision system by the same surgeon (M.N). All cases completed the three-month follow up. The subjects were asked to grade the ocular pain on the visual analog scale.[17 (link)18 (link)] The VAS consisted of a 10-cm line, with 0 on one end representing no pain and 10 on the other representing the worst pain ever experienced. A subject marked on this line to indicate the severity of his or her pain experience. The VAS was filled up by the patients on Day 1, Day 30, and Day 90. Intraocular inflammation was graded on each visit by an investigator, masked to the study group (S.L.), using the Standardization of Uveitis Nomenclature Working Group grading classification. According to this classification, less than one cell (in a 1 mm2 field illuminating the anterior chamber) is taken as grade 0, 1 to 5 cells as grade 0.5, 6 to 15 cells grade 1, 16 to 25 cells as grade 2, 26 to 50 cells as grade 3, and more than 50 cells as grade 4. Lid edema was graded as follows: Minimal swelling with lid creases visible was grade 1, moderate swelling with skin creases affected was grade 2, marked swelling when eye lids could be opened actively was grade 3, and extreme swelling when eyelids could not be opened actively was grade 4. Conjunctival chemosis was taken as grade 1 if it involved 30% of the conjunctiva, grade 2 if it involved 30-70% of the conjunctiva, and grade 3 if it involved 70-100% of the conjunctiva. Conjunctival hyperemia was graded as grade 0 for no hyperemia, grade 1 for sectoral engorgement of vessels, grade 2 for diffuse engorgement, and grade 3 for significant engorgement.
Best corrected visual acuity was obtained on Snellen Visual acuity charts at each visit.
Subjects self-administered the drops in both the groups, with group 1 receiving nepafenac (Nevanac, Alcon Laboratories, Inc. Fort Worth, Texas, USA) three times in a day for six weeks and group 2 receiving Pred Forte (Allergan, Inc. Irvine, CA, U.S.A.) beginning six times a day for week one and four times a day till week four, two times a day for week five, and once a day for week six. All the patients received prophylactic antibiotics for four weeks and atropine sulfate 1% HS for a week. All the patients also received a diclofenac sodium 100 mg suppository preoperatively and diclofenac sodium 50 mg tablet postoperatively twice per day, for five days.
The descriptive statistics were calculated for case characteristics. Group comparisons were performed with the Wilcoxon rank-sum test, using the two-sided analysis. P < 0.05 was considered significant. Snellen visual acuity was converted to logMAR units for analysis purposes.
