JMIR Publications

ABSTRACT

Background:

Pterygium and cataract frequently co-exist in populations with high ultraviolet light exposure, particularly in rural India. Both conditions impair visual acuity and reduce quality of life. Simultaneous small incision cataract surgery (SICS) combined with pterygium excision offers the advantages of a single surgical session, faster rehabilitation, and lower cost compared with sequential procedures. However, SICS employs a superior scleral tunnel incision of 6.5 to 7 mm, which itself induces against-the-rule surgically induced astigmatism. The net astigmatic outcome of simultaneous SICS and pterygium excision has not been prospectively characterised in a resource-limited setting.

Objective:

This protocol describes a prospective, single-arm interventional study designed to quantify the change in magnitude and axis of corneal astigmatism from baseline to Day 30 following a protocol-defined simultaneous surgical intervention consisting of manual SICS with posterior chamber intraocular lens implantation followed by primary nasal pterygium excision using the bare sclera technique in a single operative sitting.

Methods:

This is a prospective, single-arm interventional study with within-participant comparison conducted at the Department of Ophthalmology, Acharya Vinoba Bhave Rural Hospital, DMIHER (Deemed University), Wardha, India. All enrolled patients (n=100, aged ≥35 years with visually significant cataract and grade 1–2 nasal primary pterygium) receive the standardised surgical intervention: manual SICS with posterior chamber IOL implantation followed by primary nasal pterygium excision using the bare sclera technique in a single operative sitting. Sample size (n=100) was calculated using McNemar’s test for paired proportions, assuming 9.45% preoperative and 31.49% postoperative prevalence of clinically significant astigmatism (>1.0 D, a threshold representing astigmatism that commonly warrants spectacle correction), with α=0.05 and 95% power (minimum n=88), adjusted for 10–15% attrition. The primary outcome is change in keratometric corneal astigmatism (diopters and axis) from baseline to Day 30. Secondary outcomes include Alpins vector analysis of surgically induced astigmatism, correlation of pterygium size with preoperative astigmatism, change in uncorrected and best-corrected visual acuity, refractive surprise rate, pterygium recurrence, patient satisfaction (pilot-tested questionnaire), and complications. Follow-up assessments occur at Day 1, Day 15, and Day 30.

Results:

Ethical approval for the study was obtained from the Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research on June 30, 2025. Participant recruitment began on November 1, 2025 and is ongoing at Acharya Vinoba Bhave Rural Hospital, Wardha. Data collection is expected to continue through 2027, with results anticipated to be reported in 2028.

Conclusions:

This protocol will generate prospective interventional data evaluating corneal astigmatism and visual outcomes of a protocol-defined simultaneous surgical procedure combining manual SICS and bare sclera pterygium excision in a high-volume rural ophthalmology setting. Findings will inform surgical planning, IOL power selection strategies, and patient counselling in resource-limited settings where SICS is the predominant cataract surgical technique. Clinical Trial: Clinical Trials Registry of India (CTRI): CTRI/2025/10/095785; Registered October 9, 2025 (Prospective).