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Authors want to investigate light versus ROP severity

Light monitors were found to have a significant flaw

"We will have put a controversy to rest"

Progress Report submitted on February 1, 1997, by James D. Reynolds, M.D., at Buffalo Children's Hospital, to the Program Director at the National Eye Institute

PROGRESS REPORT

A. Specific Aims

The aims of the LIGHT-ROP trial continue. Our primary question as to whether ambient light exposure has any impact on the incidence of ROP remains unchanged. Our additional aim to investigate the connection between light and ROP severity also continues and our increased enrollment may yield enough data to enable analysis.

[Note: the authors want to work out what light levels cause how much eye damage, as if preemies were guinea pigs, instead of just lowering the lights at the first hint or even suspicion of danger.]

However, the incidence of severe ROP is low enough that even 400 enrollees may not yield robust results on this question. Finally, our desire to adequately measure ambient lighting also continues although we have had to change our methods as our feasibility trial gained experience.

B. Studies and Results

The LIGHT-ROP feasibility trial was approved for funding April 1, 1995. We are now nearing the end of our second year. Patient enrollment began on 7/19/95 in Buffalo, 7/12/95 in Dallas, and 11/28/95 in our subsequently added center of San Antonio.

The total number of enrolled participants on 1/31/97 was 376. The three centers combined have enrolled a broad crosssection of society representatives including gender and minority status. (See enclosed tables) We expect to have over 400 subjects enrolled at the conclusion of our enrollment period on 3/21/97. This extended enrollment period was requested by the DSMCbased on their review results.  The project director is, of course, masked to these results and discussions.

Once enrollment is complete, on 3/21/97, results should be available three to four months after this, on or about 7/1/97 and six month follow-up visits should be complete in January 1998. Hence all centers will be very actively engaged in patient monitoring for the bulk of year three of the grant.

No meaningful complications or side effects have occurred thus far in either group.

Our light monitoring process has undergone a methodological change.  Our continuous, on-line light monitors were found to have a significant flaw, rendering that data false and unfortunately useless.

[Note: This was written one month before the end of the almost two year long study.]

However we rapidly converted to another monitoring system. Although not continuous or on-line it is extremely reliable.  We are currently using commercial scientific grade light monitors and we are obtaining readings for each baby manually performed by the SCC. These readings are conducted at each random goggle check period resulting in 24 readings per week per individual.

We are still working on our prototype continuous monitors and hope to achieve success with these yet.

C. Significance

The potential significance of the study remains unchanged. We hope to answer whether ambient light impacts the incidence of ROP. If positive, we may be able to offer an easy and inexpensive preventive therapy. If negative we will have put a controversy to rest.

D. Plans

We intend to continue patient follow-up in year three in both the acute and long-term follow-up phases.

E. Publications

We have begun work on a design paper. All results continue to be masked.

F. Project-Generated Resources

None

G. Invention and Patents

None

Continue reading the discussion of the frauds and ethics violations in this study.